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Primary Endpoint

Complete Clearance Seen With a 5-Day Treatment Course1

5X MORE PATIENTS ACHIEVED COMPLETE CLEARANCE WITH KLISYRI® VS VEHICLE2*

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100% AK clearance rates for the two Phase 3 studies for all subjects was 44% (n/N=77/175) KLISYRI® vs 5% (n/N=8/176) vehicle in study 1, and 54% (n/N=97/178) KLISYRI® vs 13% (n/N=22/73) vehicle in study 21†

*

Calculation based on pooled analysis of 702 patients from two Phase 3 studies evaluating all treatment locations (face or scalp): 49% KLISYRI® patients vs 9% vehicle.2

STUDY 1 (% OF PATIENTS WITH complete CLEARANCE ON DAY 57)1†

chart showing 50% face and 30% scalp clearance
SCALP
Before KLISYRI®
After KLISYRI®
SLIDE ARROWS TO SEE BEFORE AND AFTER RESULTS
slider icon
skin image after treatment with Klisyri
BASELINE DAY 57

Actual clinical trial subject. Results may vary.

STUDY 2 (% OF PATIENTS WITH complete CLEARANCE ON DAY 57)1†

chart showing 61% face and 41% scalp clearance

P<0.0001 vs vehicle.3,4

FACE
Before KLISYRI®
After KLISYRI®
SLIDE ARROWS TO SEE BEFORE AND AFTER RESULTS
slider icon
skin image after treatment with Klisyri
BASELINE DAY 57

Actual clinical trial subject. Results may vary.


Secondary Endpoint

MORE THAN 3/4 OF PATIENTS HAD ≥75% LESION CLEARANCE ON THE FACE; MORE THAN 1/2 HAD ≥75% LESION CLEARANCE ON THE SCALP WITH KLISYRI®1‡

STUDY 1 (% OF PATIENTS WITH ≥75% CLEARANCE ON DAY 57)1‡

chart showing 76% face and 52% scalp clearance
FACE
Before KLISYRI®
After KLISYRI®
SLIDE ARROWS TO SEE BEFORE AND AFTER RESULTS
slider icon
skin image after treatment with Klisyri
BASELINE DAY 57

Actual clinical trial subject. Results may vary.

STUDY 2 (% OF PATIENTS WITH ≥75% CLEARANCE ON DAY 57)1‡

chart showing 80% face and 69% scalp clearance

P<0.0001 vs vehicle.3,4

SCALP
Before KLISYRI®
After KLISYRI®
SLIDE ARROWS TO SEE BEFORE AND AFTER RESULTS
slider icon
skin image after treatment with Klisyri
BASELINE DAY 57

Actual clinical trial subject. Results may vary.


SIGNIFICANT REDUCTION OF LESIONS with KLISYRI®2
Chart showing reduction in lesions
teal bullet point

Reduction in AK lesion count to Day 57 was significantly greater (P<0.0001) than vehicle for all postbaseline visits until day 572

KLISYRI® was studied in two phase 3 clinical trials1

STUDY DESIGN

KLISYRI®: EVALUATED IN THE LARGEST CLINICAL TRIAL PROGRAM OF A TOPICAL Rx TREATMENT FOR AK1,5

702 patients
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Identical, double-blind, randomized, vehicle-controlled clinical trials—1:1 randomization1

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Treatment groups were comparable across all demographics and baseline characteristics, including AK lesion count and distribution on the face or scalp1

4 to 8 lesions
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Clinically typical, visible, and discrete AK lesions in a contiguous 25 cm2 area

STUDY ENDPOINTS

Primary Endpoint 100% clearance of AK lesions (complete)1. Secondary Endpoint greater than or equal to 75% reduction in lesion count of AK lesions (partial)1.
5-DAY TREATMENT

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Subjects received 5 consecutive days of once-daily treatment with either KLISYRI® (n=353) or vehicle control (n=349) to the treatment field1

Important Safety Information

Indication

KLISYRI is a microtubule inhibitor indicated for the topical treatment of actinic keratosis of the face or scalp.

Important Safety Information

Warnings and Precautions

Ophthalmic Adverse Reactions

KLISYRI may cause eye irritation. Avoid transfer of the drug into the eyes and to the periocular area during and after application. Wash hands immediately after application. If accidental exposure occurs, instruct patient to flush eyes with water and seek medical care as soon as possible.

Local Skin Reactions

Local skin reactions, including severe reactions (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) in the treated area can occur after topical application of KLISYRI. Avoid use until skin is healed from any previous drug, procedure, or surgical treatment. Occlusion after topical application of KLISYRI is more likely to result in irritation.

Adverse Reactions

The most common adverse reactions (incidence ≥2%) were local skin reactions, application site pruritus, and application site pain.

Please see full Prescribing Information.

To report an adverse event or product complaint, call or email: Medical Affairs and Customer Relations • Phone: 1-866-665-2782 • Fax: 510-595-8183 • Email: almirallmc@eversana.com

Important Safety Information

Indication

KLISYRI is a microtubule inhibitor indicated for the topical treatment of actinic keratosis of the face or scalp.

Important Safety Information

Warnings and Precautions

Ophthalmic Adverse Reactions

KLISYRI may cause eye irritation. Avoid transfer of the drug into the eyes and to the periocular area during and after application. Wash hands immediately after application. If accidental exposure occurs, instruct patient to flush eyes with water and seek medical care as soon as possible.

Local Skin Reactions

Local skin reactions, including severe reactions (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) in the treated area can occur after topical application of KLISYRI. Avoid use until skin is healed from any previous drug, procedure, or surgical treatment. Occlusion after topical application of KLISYRI is more likely to result in irritation.

Adverse Reactions

The most common adverse reactions (incidence ≥2%) were local skin reactions, application site pruritus, and application site pain.

Please see full Prescribing Information.

To report an adverse event or product complaint, call or email: Medical Affairs and Customer Relations • Phone: 1-866-665-2782 • Fax: 510-595-8183 • Email: almirallmc@eversana.com

References:

1. KLISYRI [package insert]. Exton, PA: Almirall, LLC, 2020. 2. Data on file. 2021. Pooled Data Analysis. 3. Data on file. 2019. KX01-AK-004. 4. Data on file. 2019. KX01-AK-003. 5. Data on file. 2021. Pivotal Clinical Trials.

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KLISYRI® is a registered trademark of Almirall, LLC. © Copyright 2005-2021. All Rights Reserved. Almirall, LLC, Exton, PA 19341 US-TIRBA-2100057 02/2021

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KLISYRI® is a registered trademark of Almirall, LLC. © Copyright 2005-2021. All Rights Reserved. Almirall, LLC, Exton, PA 19341 US-TIRBA-2100057 02/2021

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